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Lead role for Sarasota in vision breakthrough

By BARBARA PETERS SMITH

Published: Friday, February 15, 2013 at 1:00 a.m.

Last Modified: Thursday, February 14, 2013 at 9:58 p.m.

With Florida's first federally approved procedure to implant a telescope the size of a large diamond inside a Venice woman's eye, Sarasota this month became the statewide referral center for a new way to treat dry age-related macular degeneration.

Marc H. Levy, the neuro-ophthalmologist who conducted clinical trials of the device a decade ago, inserted the quartz-enclosed device into the eye of Leslie Vlontis, 81, at Sarasota Memorial Cape Surgery Center on Feb. 4.

He reported Thursday that one day after the operation, when her bandage was removed, Vlontis said, "I think I'm going to like this."

Vlontis declined to talk to reporters Thursday, but this week she will be studied by 65 physicians who are in town to take a look at the procedure.

The outpatient surgery, which takes just over an hour, partially restores a patient's ability to watch television or recognize a friendly face, by magnifying objects at the center of the visual field.

Before the procedure, Vlontis said she looked forward to "recognizing people from a distance instead of their voices. I've talked to a lot of people I thought were friends of mine."

About 15 million people in the United States have some form of macular degeneration, which destroys the clear, "straight-ahead" vision needed for reading, driving and performing other daily tasks.

Of those, 2 million have an advanced form of the disorder, and about half a million people over 60 are legally blind as a result.

Local test site

The 4-by-13-millimeter telescope, invented by an Israeli eye doctor, was tested from 2002 to 2004 on 217 patients over age 50 at 28 sites in the U.S.

Sarasota Memorial Hospital was the only test site in Florida.

Of the five patients Levy treated here, three have since died and one moved away. The fifth patient, Eloise Hedstrom, 83, lives in the Glenridge retirement community in Palmer Ranch.

"I remember that it took a while to have everything focus," Hedstrom recalled this week. "I remember very clearly, perhaps a couple of weeks after it had been done, I went to hear a concert. I opened one eye" -- the one with the implant -- "and, oh my goodness, I could see faces and tuxedo-wearing men playing instruments. I hadn't been able to see that clearly and beautifully in quite a while."

Like others in the early trials, Hedstrom has seen her vision diminish over the last decade.

"Nothing is perfect," she said. "As time goes on, it's been fading away. But it's still my favorite eye."

Levy said that since the testing phase, he has "gone gray" waiting for approval of the procedure by the U.S. Food and Drug Administration.

In July 2010, the FDA decided it had enough data to give the go-ahead.

Then it was another two years before Medicare reimbursement became available in Florida, in October 2012.

The program for Americans over 65 covers 80 percent of the $19,000 cost, Levy said, which includes about $15,000 for the telescope itself.

For now, only surgeons who conducted the clinical trials can implant the device.

Strict criteria

Vlontis, whose vision is already improving, will be given eyedrops for another four weeks or so, and will work for several months with a visual rehabilitation specialist to learn how to use her enhanced eye.

Levy said the implant goes into whichever eye has the hazier vision. Then the patient uses "what was previously the better eye for peripheral vision, and the two images merge."

Drugs are available to slow the progression of macular degeneration, but this procedure is the only treatment so far to reverse the effects of dry age-related macular degeneration.

Levy said other applications might be approved in the future, but for the moment patients must see several specialists and meet strict criteria for the operation.

"This device is not going to render anybody able to get their driver's license again," he said.

But the average improvement so far is the ability to read two lines down on an eye chart -- with some patients improving by as many as five lines.

<p>With Florida's first federally approved procedure to implant a telescope the size of a large diamond inside a Venice woman's eye, Sarasota this month became the statewide referral center for a new way to treat dry age-related macular degeneration.</p><p>Marc H. Levy, the neuro-ophthalmologist who conducted clinical trials of the device a decade ago, inserted the quartz-enclosed device into the eye of Leslie Vlontis, 81, at Sarasota Memorial Cape Surgery Center on Feb. 4.</p><p>He reported Thursday that one day after the operation, when her bandage was removed, Vlontis said, "I think I'm going to like this."</p><p>Vlontis declined to talk to reporters Thursday, but this week she will be studied by 65 physicians who are in town to take a look at the procedure.</p><p>The outpatient surgery, which takes just over an hour, partially restores a patient's ability to watch television or recognize a friendly face, by magnifying objects at the center of the visual field.</p><p>Before the procedure, Vlontis said she looked forward to "recognizing people from a distance instead of their voices. I've talked to a lot of people I thought were friends of mine."</p><p>About 15 million people in the United States have some form of macular degeneration, which destroys the clear, "straight-ahead" vision needed for reading, driving and performing other daily tasks.</p><p>Of those, 2 million have an advanced form of the disorder, and about half a million people over 60 are legally blind as a result.</p><p>Local test site</p><p>The 4-by-13-millimeter telescope, invented by an Israeli eye doctor, was tested from 2002 to 2004 on 217 patients over age 50 at 28 sites in the U.S.</p><p>Sarasota Memorial Hospital was the only test site in Florida.</p><p>Of the five patients Levy treated here, three have since died and one moved away. The fifth patient, Eloise Hedstrom, 83, lives in the Glenridge retirement community in Palmer Ranch.</p><p>"I remember that it took a while to have everything focus," Hedstrom recalled this week. "I remember very clearly, perhaps a couple of weeks after it had been done, I went to hear a concert. I opened one eye" -- the one with the implant -- "and, oh my goodness, I could see faces and tuxedo-wearing men playing instruments. I hadn't been able to see that clearly and beautifully in quite a while."</p><p>Like others in the early trials, Hedstrom has seen her vision diminish over the last decade.</p><p>"Nothing is perfect," she said. "As time goes on, it's been fading away. But it's still my favorite eye."</p><p>Levy said that since the testing phase, he has "gone gray" waiting for approval of the procedure by the U.S. Food and Drug Administration.</p><p>In July 2010, the FDA decided it had enough data to give the go-ahead.</p><p>Then it was another two years before Medicare reimbursement became available in Florida, in October 2012.</p><p>The program for Americans over 65 covers 80 percent of the $19,000 cost, Levy said, which includes about $15,000 for the telescope itself.</p><p>For now, only surgeons who conducted the clinical trials can implant the device.</p><p>Strict criteria</p><p>Vlontis, whose vision is already improving, will be given eyedrops for another four weeks or so, and will work for several months with a visual rehabilitation specialist to learn how to use her enhanced eye.</p><p>Levy said the implant goes into whichever eye has the hazier vision. Then the patient uses "what was previously the better eye for peripheral vision, and the two images merge."</p><p>Drugs are available to slow the progression of macular degeneration, but this procedure is the only treatment so far to reverse the effects of dry age-related macular degeneration.</p><p>Levy said other applications might be approved in the future, but for the moment patients must see several specialists and meet strict criteria for the operation.</p><p>"This device is not going to render anybody able to get their driver's license again," he said.</p><p>But the average improvement so far is the ability to read two lines down on an eye chart -- with some patients improving by as many as five lines.</p><p><empty></p><p><empty></p>